SILDENAFIL NORMON 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Sildenafilo Normon 100 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.Keep this leaflet. You may need to read it again..

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Sildenafilo Normon is and what it is used for
2. What you need to know before you take Sildenafilo Normon
3. How to take Sildenafilo Normon
4. Possible side effects
5. Storage of Sildenafilo Normon
6. Contents of the pack and other information

1. What Sildenafilo Normon is and what it is used for

Sildenafilo belongs to a group of medicines called phosphodiesterase type 5 inhibitors. It works by dilating the blood vessels in the penis, allowing blood flow when you are sexually stimulated. Sildenafilo will only help you to get an erection if you are sexually stimulated.

Sildenafilo is indicated for the treatment of erectile dysfunction in adult men, sometimes called impotence. This occurs when a man cannot get or maintain an erection that is sufficient for satisfactory sexual activity.

2. What you need to know before you take Sildenafilo Normon

Do not take Sildenafilo Normon:

• If you are allergic (hypersensitive) to sildenafilo or any of the other ingredients of this medicine (listed in section 6).
• If you are taking medicines called nitrates, as the combination can cause a dangerous decrease in your blood pressure. Consult your doctor if you are taking any of these medicines, which are often given to relieve angina pectoris (or "chest pain"). If you are unsure, consult your doctor or pharmacist.
• If you are using any of the medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination can cause a dangerous decrease in your blood pressure.
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors, such as Sildenafilo Normon, have shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• If you have a serious heart or liver problem.
• If you have recently had a stroke or heart attack, or if you have low blood pressure.
• If you have a rare inherited eye disease, such as retinitis pigmentosa.
• If you have previously experienced a loss of vision due to a non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sildenafilo Normon:

Tell your doctor:

• If you have sickle cell anemia (a blood disorder), leukemia (cancer of the blood cells), or multiple myeloma (cancer of the bone marrow)
• If you have a penis deformity or Peyronie's disease.
• If you have heart problems. In this case, your doctor should carefully check if your heart can withstand the extra strain of having sex.
• If you currently have stomach ulcers or bleeding disorders (such as hemophilia).
• If you experience a sudden decrease or loss of vision, stop taking Sildenafilo Normon and contact your doctor immediately.

It is not recommended to use sildenafilo at the same time as any other oral or local treatment for erectile dysfunction.

You must not take Sildenafilo Normon with treatments for pulmonary arterial hypertension (PAH) that contain sildenafilo or any other PDE5 inhibitor.

You must not take Sildenafilo Normon if you do not have erectile dysfunction.

The use of Sildenafilo Normon is not indicated in women.

Special considerations in patients with kidney or liver problems

You should inform your doctor if you have kidney or liver problems. Your doctor may decide to reduce your dose.

Children and adolescents

The use of Sildenafilo Normon is not indicated in persons under 18 years of age.

Other medicines and Sildenafilo Normon

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Sildenafilo Normon tablets may interfere with some medicines, especially those used to treat angina pectoris. In case of a medical emergency, you should inform any healthcare professional that you are taking Sildenafilo Normon and when you took it. Do not take Sildenafilo Normon with other medicines unless your doctor advises you to.

You must not take Sildenafilo Normon if you are taking medicines called nitrates, as the combination of these products can cause a dangerous decrease in your blood pressure. Always inform your doctor or pharmacist if you are taking any of these medicines, which are often used to relieve angina pectoris (or "chest pain").

You must not take Sildenafilo Normon if you are taking medicines called nitric oxide donors, such as amyl nitrite ("poppers"), as the combination of these can also cause a dangerous decrease in your blood pressure.

Tell your doctor or pharmacist if you are taking riociguat.

If you are taking medicines known as protease inhibitors, such as those used to treat HIV, your doctor may recommend that you start treatment with the lowest dose (25 mg) of Sildenafilo Normon.

Some patients who are receiving an alpha-blocker, a medicine used to treat high blood pressure or prostate enlargement, may experience dizziness or lightheadedness, which can be caused by a decrease in blood pressure when sitting or standing up quickly. Some patients have experienced these symptoms when taking sildenafilo with alpha-blockers. This is more likely to occur within 4 hours of taking sildenafilo. To minimize the likelihood of these symptoms, you should be taking your daily dose of alpha-blockers regularly before starting Sildenafilo Normon. Your doctor may advise you to start treatment with the lower dose (25 mg) of Sildenafilo Normon.

Tell your doctor or pharmacist if you are taking medicines that contain sacubitril/valsartan, used to treat heart failure.

Taking Sildenafilo Normon with food, drinks, and alcohol

Sildenafilo Normon can be taken with or without food. However, you may notice that Sildenafilo Normon takes a little longer to work if you take it with a large meal.

Consuming alcohol can temporarily make it more difficult to get an erection. Therefore, to get the maximum benefit from the medicine, it is recommended not to drink large amounts of alcohol before taking Sildenafilo Normon.

Pregnancy and breastfeeding

The use of Sildenafilo Normon is not indicated in women.

Driving and using machines

Sildenafilo Normon can cause dizziness and affect vision. You should know how you react to Sildenafilo Normon before driving vehicles or using machinery.

Sildenafilo Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

3. How to take Sildenafilo Normon

Follow exactly the administration instructions of sildenafilo indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. The recommended starting dose is 50 mg.

Do not take Sildenafilo Normon more than once a day.

Do not take sildenafilo with other medicines that contain sildenafilo.

You should take sildenafilo about an hour before you plan to have sex.

Swallow the tablet whole with a glass of water.

If you notice that the effect of sildenafilo is too strong or too weak, tell your doctor or pharmacist.

Sildenafilo will only help you to get an erection if you are sexually stimulated. The time it takes for sildenafilo to work varies from person to person, usually between half an hour and one hour. The effect of this medicine can be delayed if you take it with a large meal.

In case sildenafilo does not help you to get an erection or if the erection is not maintained long enough to complete sexual intercourse, consult your doctor.

If you take more Sildenafilo Normon than you should:

You may experience an increase in side effects and their severity. Doses above 100 mg do not increase efficacy.

Do not take more tablets than recommended by your doctor.

Contact your doctor if you have taken more tablets than advised.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sildenafilo Normon can cause side effects, although not everybody gets them. The side effects associated with the use of sildenafilo are generally mild to moderate and short-lived.

If you experience any of the following serious side effects, stop taking Sildenafilo Normon and seek medical attention immediately:

• Allergic reaction - this occurs with rare frequency(may affect up to 1 in 100 people)

The symptoms include sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.

• Chest pain - this occurs with rare frequency

If they occur during or after having sex:

• Sit in a semi-upright position and try to relax.
• Do not use nitratesto treat chest pain.

• Prolonged and sometimes painful erections - this occurs very rarely(may affect up to 1 in 1,000 people)

If you have an erection that lasts more than 4 hours, you should contact your doctor immediately.

• Sudden decrease or loss of vision - this occurs very rarely

• Severe skin reactions - this occurs very rarely

The symptoms can include severe scaling and swelling of the skin, blistering of the mouth, genitals, and around the eyes, as well as fever.

• Seizures or fits - this occurs very rarely

Other side effects:

Very common(may affect more than 1 in 10 people): headache.

Common(may affect up to 1 in 10 people): nausea, facial flushing, feeling hot (including a feeling of warmth in the upper body), indigestion, abnormal color perception, blurred vision, visual disturbance, nasal congestion, and dizziness.

Uncommon(may affect up to 1 in 100 people): vomiting, skin rash, eye irritation, eye discharge/ red eyes, eye pain, seeing flashes of light, increased light sensitivity, tearing, palpitations, rapid heartbeat, high blood pressure, low blood pressure, muscle pain, feeling sleepy, reduced sense of touch, vertigo, ringing in the ears, dry mouth, blocked or stuffy nose, inflammation of the nasal mucosa (including symptoms such as runny nose, sneezing, and nasal congestion), pain in the upper abdomen, gastroesophageal reflux disease (including symptoms such as heartburn), blood in urine, pain in arms or legs, nosebleeds, feeling hot and feeling tired.

Rare(may affect up to 1 in 1,000 people): fainting, stroke, heart attack, irregular heartbeat, temporary decrease in blood flow to some parts of the brain, feeling of compression in the throat, numbness in the mouth, bleeding in the back of the eye, double vision, decreased sharpness of vision, abnormal sensation in the eye, eye swelling or eyelid swelling, small particles or spots in the vision, seeing halos around lights, dilation of the pupil of the eye, change in color of the white part of the eye, bleeding from the penis, presence of blood in the semen, dry nose, swelling inside the nose, feeling irritable, and sudden decrease or loss of hearing.

During post-marketing experience, unstable angina (heart disease) and sudden death have been rarely reported. It is worth noting that most men who experienced these side effects, although not all of them, had pre-existing heart problems before taking this medicine. It is not possible to determine if these side effects were directly related to Sildenafilo Normon.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sildenafilo Normon

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Sildenafilo Normon

• The active substance is sildenafilo. Each tablet contains 100 mg of sildenafilo (as citrate).
• The other ingredients are:

Core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, magnesium stearate, colloidal silica, and sodium croscarmellose.

Coating: hypromellose, titanium dioxide (E-171), macrogol 6000, talc, and indigo carmine lake (E-132).

Appearance of the product and contents of the pack

Sildenafilo Normon 100 mg: film-coated tablets, blue, elongated, and with serigraphy (100).

It is presented in packs of 4, 8, and 12 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid, Spain

Date of last revision of this leaflet:May 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72232/P_72232.html